VP Regulatory Affairs & Quality Assurance

  • ExecuNet
  • San Francisco, CA, USA
  • Aug 01, 2020
Full time Government

Job Description

The Vice President of Regulatory Affairs and Quality Assurance reports to the Chief Medical Officer and is responsible for developing and directing Company's regulatory strategy, objectives, policies and programs from IND planning through NDA and commercialization. He/she will serve as the regulatory lead for Company developing and providing strategic regulatory direction and guidance to R&D on corporate projects and key strategic business initiatives to achieve corporate objectives. He/she will also be responsible for implementing, maintaining, and overseeing audit-ready quality systems. As the company grows, the individual will build and lead a team of regulatory and quality professionals to meet global development and regulatory requirements.

RESPONSIBILITIES:

  • Act as the primary interface with FDA, Health Canada and ex-US Health Authorities; (may delegate to service provider(s) for ex-US interactions)
  • Lead the development of strategic plans and tactical implementation leading to the creation and submission of regulatory documents (INDs, NDAs, CTAs, MAAs, supplemental NDAs, and other relevant regulatory filings) working in close collaboration with CMC, clinical, nonclinical and legal groups.
  • Represent all aspects of Regulatory Affairs at the Development Senior Leadership Team
  • Lead in the preparation and assembly of clinical submissions for regulatory agencies (protocols, informational amendments, annual reports and safety reports)
  • Manage, mentor and train Regulatory Affairs and Quality Assurance personnel
  • Develop, maintain and improve Regulatory Affairs and document management systems to support internal activities as well as activities of service providers
  • Provide expertise in the interpretation, guidance and training of FDA regulations and regulatory advice to other functional groups and executive management
  • Troubleshoot and resolve regulatory management and scientific issues on projects as required in collaboration with functional groups
  • Manage outside regulatory and QA consultants

REQUIREMENTS:

  • Bachelors/Masters/Doctors degree in a life scientific discipline or equivalent, advanced degrees are preferred
  • At least 15 years of experience in pharmaceutical/biotechnology industry, of which a minimum of 10 years in Regulatory Affairs, is mandatory
  • Extensive experience working with the FDA and other Regulatory Authorities, with proven successful NDAs (recent experience preferred) and equivalent international regulatory submissions
  • Experience with preparation and conduct of FDA advisory committee meetings preferred
  • Strong leadership and organizational skills as well as strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills
  • High level knowledge of general biological/physical sciences and ability to apply that knowledge to complex regulatory issues
  • Writing skills that meet regulatory requirements and standards for documentation, including the ability to effectively describe complex situations
  • Ability to communicate effectively and maintain excellent relationships despite often dealing with demanding, complex or controversial issues